Compounder sold drugs illegally in seven states

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A Woburn compounding pharmacy that recalled two dozen drugs this week has said it distributed directly to patients and doctors in up to 21 states, but a Globe review found the company lacked the required license to operate as a pharmacy in at least a third of those states.

The California pharmacy board on Wednesday ordered Pallimed Solutions Inc. to stop shipping prescription drugs into that state because it had no license. Texas will consider taking similar action, the pharmacy board director said. State officials in Illinois, Maine, Wisconsin, Vermont, and Virginia — all listed on the distribution list in Pallimed’s recall notice — said the company was not properly licensed to operate within their borders.

The possibility that the pharmacy was operating in states where it is not licensed points to continued gaps in the oversight of compounding pharmacies exposed last year when tainted steroids produced at New England Compounding Center caused a national crisis.

The Framingham pharmacy’s drugs sickened hundreds of people and have been linked to 51 deaths. Regulators have said New England Compounding was acting more like a drug manufacturer, shipping products in bulk to providers nationwide though it didn’t have a federal license.

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While manufacturers are overseen by the Food and Drug Administration, it is the responsibility of compounding pharmacies to secure proper licenses for the states in which they do business.

“It’s easy to see how, given the regulatory structure, these companies can go undetected,” particularly if they are shipping drugs directly to patients’ homes, said Dr. Michael Carome, deputy director of the Health Research Group at Public Citizen, a consumer advocacy group.

Compounders are supposed to custom make drugs for individual patients who need doses or preparations that aren’t available off the shelf. Some compounders, including Pallimed and New England Compounding, specialized in mixing sterile products, which can include injections, intravenous solutions, and eye drops.

Pallimed announced on Tuesday
that it is working with the FDA to recall all sterile compounded products it has dispensed since Jan. 1, after inspectors found still-unidentified contaminants in five vials of drugs at the company’s Woburn pharmacy.

Many of the recalled products are injections used to treat erectile dysfunction or other conditions. No patient injuries or illnesses have been reported as a result of the recall. Pallimed has said it will continue to make products that don’t require a sterile compounding process.

The company would not comment this week on how many patients might have received recalled items, where exactly it shipped its drugs, or where the pharmacy is licensed.

When asked about licensing status, Pallimed spokesman Scott Farmelant said by e-mail that “patients with out-of-state billing addresses often fill their prescriptions at Pallimed’s Massachusetts facility.” He declined to explain, citing the ongoing investigation. For the same reason, state and federal regulators would not comment specifically on the issue.

It is unclear at what scale Pallimed, which has a small staff and is located in the back of an office building in West Cummings Park, was operating. The state has said it is looking into whether the company has stayed within the scope of its Massachusetts license.

Carmen Catizone, executive director of the National Association of Boards of Pharmacy, said the system of making pharmacies responsible for securing their state licenses seemed to work until the fungal meningitis outbreak linked to New England Compounding.

“It wasn’t troubling before, but it is troubling now,” he said. “The whole game has changed.”

His organization is working to build a database of pharmacy profiles, including disciplinary records, as a free resource for regulators researching a company’s history in other states. The group has offered to contract with states to inspect out-of-state pharmacies that sell drugs within their borders.

According to a Globe review of records and interviews with state regulators, Pallimed has active licenses in eight states, including Massachusetts. In two states on Pallimed’s distribution list, Georgia and Pennsylvania, representatives said licenses are not required for out-of-state pharmacies. Pallimed did not show up in licensing databases for several other states listed in the company recall, but state officials could not be reached for confirmation.

New York regulators did not renew Pallimed’s pharmacy license in December, after the Massachusetts pharmacy board ordered Pallimed to stop making a generic form of Viagra because it was using veterinary components to fill human prescriptions. The company also was cited last year for making a too-potent batch of a painkiller that caused two people to be hospitalized.

Some officials said the licensing board in a compounding pharmacy’s home state should compare the facility’s product logs with its licenses to be sure it is complying with basic regulatory standards.

“Any legitimate pharmacy is going to make sure they have all the proper licenses and registrations that they need,” said Ronald Klein, a pharmacist and former inspector who is executive officer of Vermont’s pharmacy board.

Proposals before state and federal lawmakers could further tighten regulation of the pharmacies. A federal proposal would require compounders that are acting as manufacturers to register with the FDA.

Massachusetts is one of just three states that do not require pharmacies located out of state to be licensed in Massachusetts in order to serve patients here. That means if Pallimed were based in another state, for example, it could distribute drugs here without a Massachusetts license. A bill scheduled for a legislative hearing Tuesday would change that.

Kay Lazar of the Globe staff contributed to this report. Chelsea Conaboy can be reached at cconaboy@boston.com. Follow her on Twitter @cconaboy.

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